Kidney CancerNCT00900042
SWOG-9023, DNA Analysis of Tumor Tissue From Patients With Metastatic Kidney Cancer
An observational study of Kidney Cancer, run by SWOG Cancer Research Network.
Trial summary
RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment. PURPOSE: This laboratory study is analyzing the DNA in tumor tissue from patients with metastatic kidney cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- DNA ploidy analysis, DNA stability analysis and chromosomal translocation analysis
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Jul 1993to Jan 2003
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of renal cell carcinoma
- Any T, any N, M1 disease as specified in SWOG-8949
- Eligible for and registered on the nephrectomy arm* (arm I) of SWOG-8949 NOTE: *Patients must be registered on this study before undergoing nephrectomy on SWOG-8949
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: Cytogenetic and Flow Cytometric Analysis of : Renal Cell Carcinoma: A Companion Protocol to SWOG-8949
RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment.
PURPOSE: This laboratory study is analyzing the DNA in tumor tissue from patients with metastatic kidney cancer.
Read the detailed description
OBJECTIVES:
- Determine if cytogenetic abnormalities can predict clinical outcome, in terms of response to treatment and survival, in patients with metastatic renal cell carcinoma registered to the nephrectomy arm (arm I) of SWOG-8949.
- Correlate cytogenetic abnormalities and DNA content analysis (DNA index and S-phase fraction) with clinical outcome.
OUTLINE: This is a partially prospective, partially retrospective, multicenter, companion study.
Paraffin-embedded tumor tissue specimens from patients enrolled in SWOG-8949 are evaluated by cytogenetic analysis (e.g., presence of trisomy and loss of Y chromosome) and flow cytometric analysis (e.g., presence of nondiploid cells and presence of abnormal proliferation index).
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
- Conditions
- Kidney Cancer
- Being tested
- DNA ploidy analysis, DNA stability analysis, chromosomal translocation analysis, cytogenetic analysis, flow cytometry
- Keywords
- stage IV renal cell cancer
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA ploidy analysisGenetic
DNA stability analysisGenetic
chromosomal translocation analysisGenetic
cytogenetic analysisGenetic
flow cytometryOther
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of successes per number of evaluable samples
Success is defined as obtaining at least 10 analyzable metaphases.
Measured: up to 4 years after registration
Number of abnormalities per number of successes
Abnormality is defined as at lease one clonal chromosomal abnormality.
Measured: up to 4 years after registration
Correlation of tumor response to treatment with the type and number of abnormalities
Abnormality is defined as at lease one clonal chromosomal abnormality.
Measured: up to 4 years after registration
Correlation of time from diagnosis to development of metastatic disease with the type and number of abnormalities
Abnormality is defined as at lease one clonal chromosomal abnormality.
Measured: up to 4 years after registration
Correlation of time from first diagnosis of metastatic disease until death with the type and number of abnormalities
Abnormality is defined as at lease one clonal chromosomal abnormality.
Measured: up to 4 years after registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startJul 1993
- Primary completionDec 2002
- Study completionJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Robert P. Whitehead, MD, Study chair, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900042
- Sponsor's protocol ID
- CDR0000502305
- Other IDs
- SWOG-9023, U10CA032102
- Status last verified
- Feb 2014
- First submitted
- 9 May 2009
- Last updated
- 25 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytogenetic and Flow Cytometric Analysis of : Renal Cell Carcinoma: A Companion Protocol to SWOG-8949
- ClinicalTrials.gov ID
- NCT00900042
- Acronym / sponsor ID
- CDR0000502305
- Conditions
- Kidney Cancer
- Keywords
- stage IV renal cell cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 1993
- Primary completion
- Dec 2002 (actual)
- Study completion
- Jan 2003 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment.
PURPOSE: This laboratory study is analyzing the DNA in tumor tissue from patients with metastatic kidney cancer.
Detailed description
OBJECTIVES:
- Determine if cytogenetic abnormalities can predict clinical outcome, in terms of response to treatment and survival, in patients with metastatic renal cell carcinoma registered to the nephrectomy arm (arm I) of SWOG-8949.
- Correlate cytogenetic abnormalities and DNA content analysis (DNA index and S-phase fraction) with clinical outcome.
OUTLINE: This is a partially prospective, partially retrospective, multicenter, companion study.
Paraffin-embedded tumor tissue specimens from patients enrolled in SWOG-8949 are evaluated by cytogenetic analysis (e.g., presence of trisomy and loss of Y chromosome) and flow cytometric analysis (e.g., presence of nondiploid cells and presence of abnormal proliferation index).
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA ploidy analysis | Genetic | – |
| DNA stability analysis | Genetic | – |
| chromosomal translocation analysis | Genetic | – |
| cytogenetic analysis | Genetic | – |
| flow cytometry | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Number of successes per number of evaluable samples
Time frame: up to 4 years after registration
Success is defined as obtaining at least 10 analyzable metaphases.
Number of abnormalities per number of successes
Time frame: up to 4 years after registration
Abnormality is defined as at lease one clonal chromosomal abnormality.
Correlation of tumor response to treatment with the type and number of abnormalities
Time frame: up to 4 years after registration
Abnormality is defined as at lease one clonal chromosomal abnormality.
Correlation of time from diagnosis to development of metastatic disease with the type and number of abnormalities
Time frame: up to 4 years after registration
Abnormality is defined as at lease one clonal chromosomal abnormality.
Correlation of time from first diagnosis of metastatic disease until death with the type and number of abnormalities
Time frame: up to 4 years after registration
Abnormality is defined as at lease one clonal chromosomal abnormality.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert P. Whitehead, MD study chair
University of Texas
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Cancer, run by SWOG Cancer Research Network.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of successes per number of evaluable samples (time frame: up to 4 years after registration). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2014.